MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X420MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	33250420S
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
Date of Event	07/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that a gamma nail which had been implanted on (b)(6) 2018 was revised on (b)(6) 2018.The surgeon reported a poor reduction due to the fracture pattern and also medial bone loss in the lesser trochanter.The patient was revised to a proximal femoral plate.Update: the customer reported that the patient turned and heard a crack.She did not fall.Patient presented to clinic.Patient had non-union prior to this reported event.Revision surgery completed "usccessfully.".
Event or Problem Description
The customer reported that a gamma nail which had been implanted on (b)(6) 2018 was revised on (b)(6) 2018.The surgeon reported a poor reduction due to the fracture pattern and also medial bone loss in the lesser trochanter.The patient was revised to a proximal femoral plate.Update: the customer reported that the patient turned and heard a crack.She did not fall.Patient presentied to clinic.Patient had non-union prior to this reported event.Revision surgery completed usccessfully.
Additional Manufacturer Narrative
The reported event that long nail kit r2.0, ti, left gamma3® ø11x420mm x 125° was alleged broken could be confirmed, since the device was returned for evaluation.The device was returned for inspection and was found to be broken.The appearance of the fractured surfaces indicated the nail had broken in fatigue manner contributed by significant tensile and torsional stresses.General aspects: the gamma nail is a temporary implant.Loads on the device produced by load bearing and the patient's activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X420MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7803316
• Report Number: 0009610622-2018-01028
• Device Sequence Number: 11086009
• Product Code: HSB
• UDI-Device Identifier: 07613153313588
• UDI-Public: 07613153313588
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 33250420S
• Device Lot Number: K099C78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR